In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

The decrease in NADH is directly proportional to the GLDH activity.

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95^th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity glutamate dehydrogenase samples.

U/L

^{a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).}

µkat/L*

^{a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).}

^{*calculated by unit conversion factor}

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L.

Icterus:

Hemolysis:

Lipemia (Intralipid):

Pyruvate: No significant interference from pyruvate up to a concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

Materials required (but not provided):

GLDH3: ACN 20610

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

Glutamate dehydrogenase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

The sample activities were between 1.40 and 76.7 U/L.

Summary

^LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

^,

^LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.

^,

^LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

R1 has to be filled into position B after reagent preparation (see Reagent handling section). R3 is in position C.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 3 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K₂‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

The decrease in NADH is directly proportional to the GLDH activity.

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95^th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity glutamate dehydrogenase samples.

U/L

^{a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).}

µkat/L*

^{a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).}

^{*calculated by unit conversion factor}

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L.

Icterus:

Hemolysis:

Lipemia (Intralipid):

Pyruvate: No significant interference from pyruvate up to a concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

GLDH3: ACN 20610

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Glutamate dehydrogenase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

The sample activities were between 1.40 and 76.7 U/L.

Summary

^LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

^,

^LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.

^,

^LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

R1 has to be filled into position B after reagent preparation (see Reagent handling section). R3 is in position C.

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 3 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K₂‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

The decrease in NADH is directly proportional to the GLDH activity.

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Lower detection limit of the test:

1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 1 U/L) will not be flagged by the instrument.

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

_{a)  Calculated with a temperature conversion factor of 1.61 (25→37 °C).}

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L (0.1 µkat/L).

Icterus:

Hemolysis:

Lipemia (Intralipid):

Pyruvate: No significant interference up to a pyruvate concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

Exceptions: Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results. Temozolomide at therapeutic concentrations may lead to erroneous results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

GLDH3: ACN 8588

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

Glutamate dehydrogenase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 94

Summary

^LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

^,

^LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.

^,

^LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum.

Plasma: Li‑heparin and K₂‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

In vitro test for the quantitative determination of the catalytic activity of GLDH (EC 1.4.1.3; glutamate dehydrogenase) in human serum and plasma on COBAS INTEGRA systems.

UV test according to a standardized method

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

The decrease in NADH is directly proportional to the GLDH activity.

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Lower detection limit of the test:
1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 21).

^{*Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).}

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”, Cat. Nos. 11322524 001 (English), 04347234 001 (German).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

Criterion: Recovery within ± 10 % of initial value.

Serum, plasma

Icterus:

Hemolysis:

Lipemia (Intralipid):

Drugs: No interference was found at therapeutic concentrations using common drug panels.

Pyruvate: No significant interference up to a pyruvate concentration of 300 µmol/L (26 mg/dL).

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on COBAS INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

Test GLDH3, test ID 0‑189

Reagent handling

R1: Connect one bottle 1 to one bottle 1a using the enclosed adapter and dissolve the lyophilizate completely in the buffer.

SR: Ready for use.

Labeling the cobas c pack MULTI

Turn the barcode labeled side of a new cobas c pack MULTI toward you. Affix the supplied GLDH3 barcode label directly over the existing barcode label.

Filling the cobas c pack MULTI

The GLDH3 cobas c pack is now ready for use.

Note

Use only the cobas c pack MULTI. Always use a newcobas cpack MULTI when preparing fresh reagent. Never reuse accessories designed for single use, as this may result in reagent contamination and could affect test results. If thecobas c pack MULTI bottles are not filled correctly, this may result in faulty reagent pipetting and could cause erroneous results.

Traceability: This method has been standardized against the Roche reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

GLDH values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer with the application GLDH3 (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

The sample activities were between 0.6 and 65.5 U/L (0.01 and 1.09 µkat/L).

Summary

^LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

^,

^LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.

^,

^LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society of Clinical Chemistry (DGKC) and optimized for performance and stability.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum: Collect serum using standard sampling tubes.
Plasma: Heparin (Li‑, Na‑, NH₄⁺‑) or EDTA (K₂‑, K₃‑) plasma.

EDTA plasma values are about 8 % lower than serum values.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH‑dependent reaction; the equilibrium is on the side of glutamate and NAD.

The decrease in NADH is directly proportional to the GLDH activity.

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. For samples with higher activities, the rerun function decreases the sample volume by a factor of 5. The results are automatically multiplied by this factor.

Lower limits of measurement

Lower detection limit of the test:

1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Limitations - interference

OrderInformation (CC Reagents - cobas + Integra)

System information

Application for serum and plasma

Storage and stability

Calibration

Specific performance data

Precision

Method comparison

Summary

Reagents - working solutions

Precautions and warnings

Quality control

Specimen collection and preparation